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Expected pharmacological effect
Causality assessment · Expected pharmacological effect
Amitriptyline and Tachycardia: is the FAERS signal real?
A written Bradford Hill assessment of one drug–event pair. The grade is a judgement about the signal, not a statement that this drug causes this event in any one person; FAERS counts are reports, not rates.
Amitriptyline ↔ Tachycardia
n=579 co-reports · PRR 7.9 · ROR 8.1
Amitriptyline, a tricyclic antidepressant, blocks cardiac sodium channels, antagonises muscarinic receptors, and inhibits noradrenaline reuptake — a combination that produces tachycardia and, at higher exposure, serious arrhythmias (579 co-reports here, PRR 7.9). Its anticholinergic and quinidine-like effects are the reason tricyclics are dangerous in overdose and require caution in cardiac disease.
Regulatory basis: amitriptyline prescribing information — cardiac conduction effects; tricyclic overdose literature.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Cardiac effects at therapeutic doses |
| Strength | met | PRR 7.9, moderate |
| Consistency | met | Consistent across tricyclics |
| Specificity | partial | Shared across the tricyclic class |
| Biological gradient | met | Worse at higher plasma levels |
| Plausibility | met | Anticholinergic and sodium-channel blockade |
| Coherence | met | Fits the pharmacology |
| Experiment | met | Overdose series quantify the effect |
| Analogy | met | Direct class analogy to imipramine |
This table is this page's own qualitative read of the literature cited above, not an automated or citation-gated assessment — see the note at the bottom of this page.
✗ No ClinicalTrials.gov results-posting trial in the top search hits for amitriptyline-hydrochloride captured tachycardia as a tracked adverse event in a usable structure. Trials of amitriptyline for depression did not report tachycardia as a structured coded adverse event.